Indian J. Pharm. Biol. Res.

2015; 3(1):82-92

CODEN (USA): IJPB07 ISSN: 2320-9267

Indian Journal of Pharmaceutical and Biological Research (IJPBR)

Journal homepage: www.ijpbr.in

Review Article
A review: Gastroretentive drug delivery system (grdds)
Meenakshi Jassal1, Ujjwal Nautiyal1*, Jyotsana Kundlas1, Devendra singh2
1
Himachal Institute of Pharmacy, Paonta sahib, HP, India
2
Tirupati life science, Paonta Sahib, HP, India

ARTICLE INFO: ABSTRACT

Article history:
Received: 25 February 2015
Received in revised form:
19 March 2015
Accepted: 21 March 2015
Available online: 31 March 2015
Keywords:
gastroretentive drug delivery system ;
floating system; swelling; expanding
system; bio/mucoadhesive system;
high density system.
One novel approach in this area is GRDDSs (Gastro Retentive Drug Delivery System).
GRDDSs can improve the controlled delivery of drugs that have an absorption window by
continuously releasing the drug for a prolonged period of time before it reaches its absorption
site.The purpose of writing this review was to investigate, compile and present the recent as
well as past literatures in more concise way with special focus on approaches which are
currently utilized in the prolongation of gastric residence time. These includes floating
system, swelling and expanding system, bio/mucoadhesive system, high density system and
other delayed gastric emptying devices. The present review addresses briefly about the
classification, formulation consideration for GRDDS, factors controlling gastric retention,
merits, demerits and applications of gastroretentive drug delivery systems.

Introduction One novel approach in this area is GRDDSs (gastro retentive

Historically, oral drug administration has been the
predominant route for drug delivery. During the past two
decades, numerous oral delivery systems have been developed
to act as drug reservoirs from which the active substance can
be released over a defined period of time at a predetermined
and controlled rate.
However, this route has several physiological problems.
Including an unpredictable gastric emptying rate that varies
from person to person, a brief gastrointestinal transit time (8-
12h), and the existence of an absorption window in the upper
small intestine for several drugs[1]These difficulties have
prompted researchers to design a drug delivery system which
can stay in the stomach for prolonged and predictable period.
Attempts are being made to develop a drug delivery system
which can provide therapeutically effective plasma drug
concentration for a longer period, thereby reducing the dosing
frequency and minimizing fluctuation in plasma drug
concentration at steady state by delivering the drug in a
controlled and reproducible manner.[2]
drug delivery system). Dosage forms that can be retained in
the stomach are called GRDDs. GRDDSs can improve the
controlled delivery of drugs that have an absorption window
by continuously releasing the drug for a prolonged period of
time before it reaches its absorption site.[3]Prolonging the
gastric retention of the drugs is sometimes desirable for
achieving therapeutic benefits of drug that are absorbed from
the proximal part of the GIT (gastro intestinal tract)or those
are less soluble in or are degraded by alkaline pH or they
encounter at the lower part of the GIT. GRDDS are beneficial
for such drugs by improving their[4]
Bioavailability
Therapeutics efficiency and
Possible reduction of the dose.
Maintenance of constant therapeutic levels over a
prolonged period and thus reduction in fluctuation in
the therapeutic levels
Reduce drug wastage
Improves solubility of drugs that are less soluble at
high pH environment (e.g. weakly basic drug like
domperidone,papaverine)

Physiology of stomach of fundus and body acts as a reservoir for undigested

Anatomically the stomach is divided into three regions materials, whereas the antrum is the main site for mixing
Fundus, Body and Antrum (pylorus) The proximal part made motions and acts as a pump for gastric emptying by propelling

*
Corresponding Author: Dr. Ujjwal Nautiyal, Associate Professor, Himachal Institute of Pharmacy, Paonta Sahib (H.P), India 82
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actions [5,6]. Gastric emptying occurs in both the fasting and
fed states. During the fasting state an interdigestive series of
electrical events take place which cycle both through stomach
and intestine every 2-3 hrs, which is called as inter digestive
myloelectric cycle or migrating myoelectric cycle (MMC)
which is further divided in to four phases. After the ingestion
of a mixed meal, the pattern of contractions changes from
fasted to that of fed state which is also termed as digestive
motility pattern [7].

Fig.1 Structure of stomach Fig.2 Schematic representation of inter digestive motility

1. Phase 1- (Basic phase) last from 30-60 minutes with rare
contractions.
2. Phase 2- (Preburst phase) last for 20-40 minutes with
intermittent action potential and contractions.
Gastroretentive drug deliverysystems
vs. conventional drugdelivery systems [8]
3. Phase 3- (Burst phase) last for 10-20 minutes which
includes intense and regular contractions for short period.
4. Phase 4-last for 0-5 minutes and occurs between phase 2
and 1 of 2 consecutive cycles.

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Factors affecting gastric retention time of the dosage form
Density- the density of the dosage form should be
less than that of the gastric contents (1.004g/ml)
Size- dosage form having diameter of more than
7.5mm have more gastric residence time than that of
9.9mm diameter dosage form.
Shape of the dosage form- the tetra hedron resided
in the stomach for longer period than other devices of
similar size. Single or multiple unit formulation-
multiple unit formulation show a more predictable
release profile and insignificant impairing of the
performance due to failure of the units. , allow co-
administration of units with different release profile
or containing incompatible substances and permit
larger margin of safety against dosage form failure
compared with single unit dosage form.
Fed or unfed state- under fasting conditions, the gi
motility is characterized by periods of strong motar
activity that occurs every 1.5-2 hrs. The MMC
sweeps undigested material from the stomach and if
the timing of the formulation coincides with that of
MMC, the GRT of the unit can be very short,
however in fast state MMC is delayed and GRT is
longer.
Nature of meal- feeding of indigestible polymers or
fatty acids can change the motility pattern of the
stomach to a fed state,thus decreasing gastric
emptying rate and prolonging drug release.
Caloric content-GRT can be increased by 4-10 with
a meal that is high in protein and fat.
Frequency of feed- The GRT can be increase over
400 min when successive meals given are compared
with the single meal due to low frequency of MMC.
Gender- mean ambulatory GRT in male (3.4hrs) is
less compared with the age and race matched female
counterparts (4.6hrs) regardless of height, weight and
body surface.
Age- people with age more than 70 have a significant
longer GRT.
Concomitant drug administration- anticholinergic
like atropine and propetheline, opiates like codeine
can prolong GRT[9-13].
Disadvantages of gastro-retentive drug deliverysystems [8]
Unsuitable for drugs with limited acidsolubility. E.g.
Phenytoin.
Unsuitable for drugs those are unstable inacidic
environment. E.g. Erythromycin.
Drugs that irritates or causes gastric lesions on slow
release. E.g. Aspirin &NSAID’s.
Drugs that absorb selectively in colon E.g.
Corticosteroid.
Review Article
Drugs that absorb equally well through GIT. E.g.
Isosorbide, dinitrate, Nifidipine.
Floating drug delivery systems require high fluid level
in stomach to float and work effectively.
Advantages of gastro-retentivedrug delivery systems
The bioavailability of therapeutic agents can be
significantly enhanced especially for those which get
metabolized in the upper GIT by this gastroretentive
drug delivery approach in comparison to the
administration of non gastroretentive drug delivery.
There are several different factors related to absorption
and transit of the drug in the gastrointestinal tract (GIT)
that act concomitantly to influence the magnitude of
drug absorption.
For drugs with relatively short half life, sustained release
may result in a flip- flop pharmacokinetics and also
enable reduced frequency of dosing with improved
patient compliance.
They also have an advantage over their conventional
system as it can be used to overcome the adversities of
the gastric retention time (GRT) as well as the gastric
emptying time (GET). As these systems are expected to
remain buoyant on the gastric fluid without affecting the
intrinsic rate of employing because their bulk density is
lower than that of the gastric fluids.
Gastroretentive drug delivery can produce prolong and
sustain release of drugs from dosage forms which avail
local therapy in the stomach and small intestine. Hence
they are useful in the treatment of disorders related to
stomach and small intestine.
The controlled, slow delivery of drug form
Gastroretentive dosage form provides sufficient local
action at the diseased site, thus mini mizingor
eliminating systemic exposure of drugs. This site-
specific drug delivery reduces undesirable effects of side
effects.
Gastroretentive dosage forms minimize the fluctuation of
drug concentrations and effects. Therefore, concentration
dependent adverse effects that are associated with peak
concentrations can be presented. This feature is of
special importance for drug with a narrow therapeutic
index.
Gastroretentive drug delivery can minimize the counter
activity of the body leading to higher Drug efficiency.
Reduction of fluctuation in drug concentration makes it
possible to obtain improved selective receptor activation.
The sustained mode of drug release from Gastroretentive
doses form enables extension ofthe time over a critical
concentration and thus enhances the pharmacological
effects and improves the chemical outcomes[14-16].
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Strategies for delaying

elaying drug transit through GIT

It is the use of natural materials or fat derivatives such as

• Pharmacological approach triethanolamine myristate, which stimulate the duodenal or
It involves the co-administration
administration or incorporation of a drug jejunal receptors to slow
w gastric emptying[17].
emptying
into the dosage form. This drug delays gastrointestinal • Pharmaceutical approach
emptying. Examples include antimuscarinics, e.g. First two approaches are not used due to toxicity problems.
propantheline. The various pharmaceutical approaches are:
are
• Physiological approach
TYPES OF GASTRORETENTIVE DOSAGE FORM

High density
system
Magnetic
system
TYPES Floating system
OF
GASTRORE
TENTIVE
Mucoadhesive DOSAGE
bioadhesive FORM Expandable
system system

Superporous
hydrogels

• High density system This approach involves formulation of dosage forms with
density that must exceed density of normal stomach content

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(1.004g/ml). These formulations are prepared by coating drug
on a heavy core or mixed with heavy inert material such as
iron powder, zinc
inc oxide, titanium dioxide, barium sulphate.
The resultant pellets can be coated with diffusion
controlledMembrane [18]These systems have some drawbacks
like they are technically difficult to manufacture with a large
amount of drug because the dry material
materia of which it is made
interacts within the gastric fluid to release its drug contents.
One other problem is that no such system is available in the
market.

Fig. 3: High density system

• Floating or low density system
By virtue of their low densities, FDDS remain afloat above the
gastric contents for prolonged periods of time and provide
continuous release of the drug. These systems in particular
have been extensively studied because they do not adversely
affect the motility of the GIT. Their dominance over the other
types of GRRDS is also evident from the large number of
floating dosage forms being commercialized and marketed
world-wide.[19]

Fig .4a:
.4 Mechanism of floating drug delivery system

Fig. 4b: Classification of floating system

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A) Effervescent System 1) Gas generating systems

Effervescent systems include use of gas generating agents,
carbonates (e.g. Sodium bicarbonate) and other organic acid
(e.g. citric acid and tartaric acid) present in the formulation to
produce carbon dioxide (CO2) gas, thus reducing the density
of system and making it float on the gastric fluid. An
alternative is the incorporation of matrix containing portion of
liquid, which produce gas that evaporate at body
temperature[20].These effervescent systems further classified
into two types.
2) Volatile liquid/vacuum systems
1) Gas generating systems
These buoyant delivery systems utilize effervescent reactions
betweenCarbonate/bicarbonate salts and citric/tartaric acid to
liberate CO2, which gets entrapped in the jellified
hydrocolloid layer of the systems thus decreasing its specific
gravity and making it to float over gastric content.[21]

Fig.5: Gas generating system

a) Single Layer Floating Tablets or Hydrodynamically
Balanced System (HBS)
These are formulated by intimately mixing the CO2
generating agents and the drug within the matrix tablet. These
have a bulk density lower than gastric fluids and therefore
remain floating in the stomach unflattering the gastric
emptying rate for a prolonged period. The drug is slowly
released at a desired rate from the floating system and after the
complete release the residual system is expelled from the
stomach. This leads to an increase in the grt and a better
control over fluctuation in plasma drug concentration[22]

Fig. 6: Single layer floating tablet

b) Bilayer Floating Tablets
These are also compressed tablet as shown in Fig and containing two layer i.e.(1)Immediate release layer (2) Sustained release layer.

Fig. 7: Bilayer floating tablet

c) Multiple Unit Type Floating Pills
These systems consist of sustained release pills as ‘seeds’
surrounded by double layers. The inner layer consists of
effervescent agents while the outer layer is of swellable
membrane layer. When the system is immersed in dissolution
medium atbody temperature, it sinks at once and then forms
swollen pills like balloons, which float as they have lower
density. This lower density is due to generation and
entrapment of CO2 within the systems[23]

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Fig.8: Multiple unit floating tablet

d) Ion exchange resin
Ion-exchange resins, a multiple-unit
unit type of oral floating
dosage system has been prepared to prolong gastric emptying
time of dosage form. The system is composed of beads of
drug-resin complex, which are loadedd with bicarbonate ions
and coated with a hydrophobic polymer. The system is so
designed that when the beads reach the stomach, chloride ions
are exchanged with bicarbonate and drug ions. The generated
CO2 is entrapped in the polymeric coated resins and causes
ca
the beads to float.[24]

Fig.9: Ion exchange resin

2) Volatile liquid containing system
The GRT of a drug delivery system can be sustainedby
incorporating an inflatable chamber, which containsa liquid
e.g. ether, cyclopentane, that gasifies at bodytemperature to
cause the inflatation of the chamber inthe stomach. The device
may also consist off abioerodible plug made up of Poly vinyl
alcohol,Polyethylene etc. that gradually dissolves causing
theinflatable chamber to release gas and collapse after
apredetermined time to permit the spontaneous ejectionof the
inflatable systems from the stomach[25]
stomach[25
a) Intragastric Floating Gastrointestinal Drug Delivery
System
These systems can be made to float in the stomach because of
floatation chamber, which may be a vacuum or filled with air
or a harmless gas, while drug reservoir is encapsulated inside a
microporouscompartment[26]
roporouscompartment[26]

Fig
Fig.10: Intragastric floating drug delivery device

b) Inflatable Gastrointestinal Delivery Systems
In these systems an inflatable chamber is incorporated, which
contains liquid ether that gasifies at body temperature to cause
the chamber to inflate in the stomach. These systems are
fabricated by loading the inflatable chamber with a drug
reservoir, which
ch can be a drug, impregnated polymeric matrix,
then encapsulated in a gelatin capsule. After oral
administration, the capsule dissolves to release the drug
reservoir together with the inflatable chamber. The inflatable
chamber automatically inflates and retains
r the drug reservoir
into the gastric fluid.[27]

Fig.11
.11: Inflatable Gastrointestinal Delivery Systems

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B) Non-Effervescent FDDS
The Non-effervescentFDDS is based on mechanism of
swelling of polymer or bioadhesion to mucosal layer in GI
tract. The mostcommonly used excipients in non-effervescent
FDDSare gel forming or highly swellable cellulose type
hydrocolloids, hydrophilic gums, polysaccharides andmatrix
forming materials such as polycarbonate,polyacrylate,
polymethacrylate, polystyrene as well asbioadhesive polymers
such as Chitosan.[28,29]The various type of this systems are
as follows:
a) Single layer floating tablets
They are formulated by intimate mixing of drug with gel-
forming hydrocolloid, which swells in contact with gastric
fluid and maintain bulk density of less than unity. The air
trapped by the swollen polymer confers buoyancy to these
dosage forms.
b)Bilayer floating tablets
A bilayer tablet contain two layer immediate release layer
which release initial dose from system while the another
sustained release layer absorbs gastric fluid, forming an
impermeable colloidal gel barrier on its surface, and maintain
a bulk density of less than unity and thereby it remains
buoyant in the stomach.
Fig.12: Hollow microspheres
3) Mucoadhesive systems
Mucoadhesive drug delivery systems contain a mucoadhesive
polymer that adheres to the gastricmucosal surface and
prolong its gastric retention in the git. The capability to adhere
to the mucus gel layermakes mucoadhesive polymers very
useful exicipientsin the GRRDS. These polymers can be
natural such assodium alginate, gelatin, guar gum etc
semisynthetic polymers such as HPMC, carbopol, sodium
carboxymethyl cellulose [33]the adhesion of polymers
withmucous membrane may be mediated by hydration,
Fig.13: Mucoadhesive systems
Review Article
c) Alginate beads
Multi-unit floating dosage forms have been developed from
freeze dried calcium alginate. Spherical beads of
approximately 2.5 mm in diameter can be prepared by
dropping sodium alginate solution into aqueous solution of
calcium chloride, causing the precipitation of calcium alginate.
The beads are then separated, snap-frozen in liquid nitrogen,
and freeze-dried at -40ºC for 24 hours, leading to the
formation of a porous system, which can maintain a floating
force for over 12 hours. These floatingbeads gave a prolonged
residence time of more than 5.5 hours.[30].
d) Hollow microspheres(microballoons)
Hollow microspheres loaded with drug in theirouter polymer
shelf were prepared by a novel emulsion solvent diffusion
method22. The ethanol/dichloromethane solution of the drug
and an enteric acrylic polymer was poured into anagitated
solution of Poly Vinyl Alcohol (PVA) that was thermally
controlled at 40ºC. The gas phase is generated in the dispersed
polymer droplet by the evaporation of dichloromethane
formed and internal cavity in the microsphere of the polymer
with drug. The microballoon floated continuously over the
surface of an acidic dissolution media containing surfactant
for more than 12 h[31,32]
bonding, or receptor mediated. In hydration mediated
adhesion, the hydrophilic polymer become sticky and
mucoadhesive upon hydration. Bonding mediated involves
mechanical or chemical bonding. Chemical bonds may
involve ionic or covalent bonds or vander Waal forces
between the polymer molecule and the mucous membrane.
Receptor mediated adhesion takes place between certain
polymers and specific receptors expressed on gastric cells. The
polymers can be cationic or anionic or neutral [34,35]
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a) Hydration – mediated adhesion
Certain hydrophilic polymers have the tendency to imbibe
large amount of water and become sticky, thereby
acquiring bioadhesive properties. The prolonged
gastroretention of the bio/muco-adhesive delivery system
is further controlled by the dissolution rate of the
polymer.[36]
b) Bonding –mediated adhesion
Adhesion of polymers to mucus/epithelial cell surface
involves varying bonding mechanism. Physical or
mechanical bonds can result from deposition and
inclusion of the adhesive material in the crevices of the
mucusa. Secondary chemical bonds, contributing to
bioadhesive properties, consist of dispersive intractions
(i.e. van der Walls intractions) and stronger specific
intraction, which include on the cell surface. The receptor
mediated hydrogen bonds. The hydrophilic functional
groups responsible for forming hydrogen bonds are the
hydroxyl (--OH) and the carboxylic groups (--COOH)[37]
c) Receptor -mediated adhesion
Certain polymers have the ability to bind to specific
receptor sites events serves as a potential approach in
bio/muco- adhesion, hence enhancing the gastric retention
of dosage forms. Certain plant lectins, like tomato lectins,
Fig.14: Swelling system
5) Superporous hydrogels
These are swellable systems that differ from conventional
types. Absorption of water by conventional hydrogel is very
slow process and several hours may be required to reach the
equilibrium states [41] during which the premature evacuation
of the dosage form may occur. Superporous hydrogel have a
pore size >100µm which swell to equilibrium size with in a
minutes, due to rapid intake of water by capillary wetting
through inter connected open pores. They swell to a larger
size and have sufficient mechanical strength to withstand the
pressure by gastric contraction. This is achieved by co-
formulation of a hydrophilic particulate material, Ac-Di-
Sol[42].
Review Article
interact specifically with the sugar groups present in
mucus or on the glycocalyx [38]
.
4) Swelling system
These are the dosage forms, which after swallowingswells
to such an extent that their exit from the pylorusis
prevented, as a result the dosage form is retained inthe
stomach for a prolonged period of time. Thesesystems are
called as plug –type system as they have the tendency to
remain lodged at the pyloric sphincter.Controlled and
sustainedrelease may be achieved by selection of
propermolecular weight polymer, and swelling of
thepolymers retard the release [39]. On coming in
contactwith gastric fluid the polymer imbibes water
andswells. The extensive swelling of these polymers is
dueto the presence of physical chemical cross links in
thehydrophilic polymer network. These cross
linksprevents the dissolution of the polymer and
hencemaintain the physical integrity of the dosage form.
In the dissolution media themembrane detached from the
core and sweeled to forma balloon that kept the unit
floating. the size of theunits increased by three to six
folds, thus the floatingability as well as the increased
dimension offered thesystem gastroretentive property[40]
6) Magnetic system
This system is based on the simple idea that the dosage form
contains a small internal magnet, and a magnet placed on the
abdomen over the position of the stomach. Using a
extracorporeal magnet, gastric residence time of the dosage
form can be enhanced for a prolonged period of time.[43]
Conclusion
Gastroretentive drug delivery systems have emerged as current
approaches of enhancing bioavailability and controlled
delivery of drugs that exhibit an absorption window.
Gastroretentive drug delivery approaches comprised mainly of
floating, bioadhesive, swelling, magnetic, and high density
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systems. These systems not only provide controlled release of
the drug but also present the drug in an absorbable form at the
regions of optimal absorption. All these drug delivery systems
have their own advantages and drawbacks. To design a
successful GRDDS, it is necessary to take into consideration
Conflict of interest statement
We declare that we have no conflict of interest.
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Cite this article as: Meenakshi Jassal, ujjwal nautiyal, Jyotsana Kundlas, Devendra singh. A review: Gastroretentive drug
delivery system (grdds).Indian J. Pharm.Biol. Res.2015; 3(1):82-92.

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